Breast CancerNCT01030250
Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The goal of this study is to increase our understanding of the adjuvant chemotherapy experience in older and younger adults by prospectively describing the longitudinal trajectory of functional status, comorbidity, and quality of life from before the initiation of chemotherapy to 6 months after the completion of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2009to 5 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer receiving adjuvant chemotherapy at City of Hope Medical Center
Who may be able to join
- Patients with stages I-III breast cancer receiving adjuvant chemotherapy
- Able to understand English
- Able to provide informed consent
- Patients of any age and performance status are eligible
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life
The goal of this study is to increase our understanding of the adjuvant chemotherapy experience in older and younger adults by prospectively describing the longitudinal trajectory of functional status, comorbidity, and quality of life from before the initiation of chemotherapy to 6 months after the completion of treatment in older (65 and older) and younger (under 65) adults. In addition, we will determine the effect of pre-treatment physical functioning on physical recovery after the course of adjuvant chemotherapy. The secondary objective of this study is to explore if factors other than chronological age (functional status, co-morbid medical conditions, nutritional status, psychological state, cognitive function, and social support) predicts which patients are more likely to experience morbidity (defined as grade 3-5 toxicity, hospitalization, dose reduction or delay, or premature discontinuation of chemotherapy course) from adjuvant chemotherapy.
Read the detailed description
60% of all cancers and 70% of cancer mortality occur in people greater than 65 years of age, defining cancer as a disease of older adults. Breast cancer is no exception to this rule where almost half of all new breast cancers in the United States are diagnosed in women 65 years of age or older1. Despite the association between cancer and aging, treatment recommendations and data acquired from prospective clinical trials in older women with breast cancer are sparse. As a result, physicians and older adults have limited data to guide treatment recommendation, make dose adjustments and manage toxicities in older adults. Aging is invariably associated with changes in physiology which can impact the pharmacokinetics and pharmacodynamics of cancer therapy. The potential for increased toxic effects in the older patient becomes an important concern. Therefore, it may not be reasonable to extrapolate data regarding toxicity from clinical trials, which primarily include younger, healthier patients. In addition, the age-related impact of adjuvant therapy on the functional status and quality of life of older versus younger adults has not been rigorously evaluated, and risk factors for toxicity, other than chronological age, need to be studied among older adults receiving anthracycline and non-anthracycline based chemotherapy regimens.
The goal of this study is to prospectively describe the longitudinal trajectory of functional status, comorbidity, and quality of life from before the initiation of chemotherapy to 6 months after the completion of treatment in older (65 and older) and younger (under 65) adults. We will determine the effect of pre-treatment physical functioning on physical recovery (ie, physical function at end of chemotherapy and 6 months later) after the course of adjuvant chemotherapy. In addition, we will explore if factors other than chronological age (functional status, comorbid medical conditions, nutritional status, psychological state, cognitive function, and social support) predict which patients are more likely to experience treatment morbidity (defined as grade 3-5 toxicity, hospitalization or urgent care visits, dose reduction or delay, or premature discontinuation of the planned chemotherapy course)
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Adjuvant Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Under 65 years | Breast cancer patients receiving adjuvant chemotherapy. Those under 65 years of age will be prospectively evaluated for outcome. | |
| Over 65 years | Breast cancer patients receiving adjuvant chemotherapy. Those over 65 years of age will be prospectively evaluated for outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe longitudinal trajectory of physical functional status and quality of life and determine if the patient assessment measure predicts morbidity in adult breast cancer patients from prior to adjuvant chemotherapy to 6 months after end of treatment.
Measured: 2 years
Secondary outcomes (1)
Assess potential biomarkers for physiologic age, including Advanced Glycation Endproducts (AGEs) and markers for oxidative stress and inflammation (e.g. 8-OHdG).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study start8 Jul 2009
- Primary completion14 Aug 2019
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Arti Hurria, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030250
- Sponsor's protocol ID
- 08242
- Other IDs
- R03AG050931
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2009
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yuan Y, Vora N, Sun CL, Li D, Soto-Perez-de-Celis E, Mortimer J, Luu TH, Somlo G, Waisman J, Smith D, Chao J, Katheria V, Synold T, Tran V, Mi S, Levi A, Arsenyan A, Choi J, Zavala L, Yost S, Hurria A. Association of pre-chemotherapy peripheral blood pro-inflammatory and coagulation factors with reduced relative dose intensity in women with breast cancer. Breast Cancer Res. 2017 Aug 29;19(1):101. doi: 10.1186/s13058-017-0895-5.
PubMed 28851415
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life
- ClinicalTrials.gov ID
- NCT01030250
- Acronym / sponsor ID
- 08242
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Adjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Jul 2009 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to increase our understanding of the adjuvant chemotherapy experience in older and younger adults by prospectively describing the longitudinal trajectory of functional status, comorbidity, and quality of life from before the initiation of chemotherapy to 6 months after the completion of treatment in older (65 and older) and younger (under 65) adults. In addition, we will determine the effect of pre-treatment physical functioning on physical recovery after the course of adjuvant chemotherapy. The secondary objective of this study is to explore if factors other than chronological age (functional status, co-morbid medical conditions, nutritional status, psychological state, cognitive function, and social support) predicts which patients are more likely to experience morbidity (defined as grade 3-5 toxicity, hospitalization, dose reduction or delay, or premature discontinuation of chemotherapy course) from adjuvant chemotherapy.
Detailed description
60% of all cancers and 70% of cancer mortality occur in people greater than 65 years of age, defining cancer as a disease of older adults. Breast cancer is no exception to this rule where almost half of all new breast cancers in the United States are diagnosed in women 65 years of age or older1. Despite the association between cancer and aging, treatment recommendations and data acquired from prospective clinical trials in older women with breast cancer are sparse. As a result, physicians and older adults have limited data to guide treatment recommendation, make dose adjustments and manage toxicities in older adults. Aging is invariably associated with changes in physiology which can impact the pharmacokinetics and pharmacodynamics of cancer therapy. The potential for increased toxic effects in the older patient becomes an important concern. Therefore, it may not be reasonable to extrapolate data regarding toxicity from clinical trials, which primarily include younger, healthier patients. In addition, the age-related impact of adjuvant therapy on the functional status and quality of life of older versus younger adults has not been rigorously evaluated, and risk factors for toxicity, other than chronological age, need to be studied among older adults receiving anthracycline and non-anthracycline based chemotherapy regimens.
The goal of this study is to prospectively describe the longitudinal trajectory of functional status, comorbidity, and quality of life from before the initiation of chemotherapy to 6 months after the completion of treatment in older (65 and older) and younger (under 65) adults. We will determine the effect of pre-treatment physical functioning on physical recovery (ie, physical function at end of chemotherapy and 6 months later) after the course of adjuvant chemotherapy. In addition, we will explore if factors other than chronological age (functional status, comorbid medical conditions, nutritional status, psychological state, cognitive function, and social support) predict which patients are more likely to experience treatment morbidity (defined as grade 3-5 toxicity, hospitalization or urgent care visits, dose reduction or delay, or premature discontinuation of the planned chemotherapy course)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Under 65 years | – | –Breast cancer patients receiving adjuvant chemotherapy. Those under 65 years of age will be prospectively evaluated for outcome. |
| Over 65 years | – | –Breast cancer patients receiving adjuvant chemotherapy. Those over 65 years of age will be prospectively evaluated for outcome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer receiving adjuvant chemotherapy at City of Hope Medical Center
Key inclusion criteria (4 listed)
- Patients with stages I-III breast cancer receiving adjuvant chemotherapy
- Able to understand English
- Able to provide informed consent
- Patients of any age and performance status are eligible
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe longitudinal trajectory of physical functional status and quality of life and determine if the patient assessment measure predicts morbidity in adult breast cancer patients from prior to adjuvant chemotherapy to 6 months after end of treatment.
Time frame: 2 years
1 secondary outcome
Assess potential biomarkers for physiologic age, including Advanced Glycation Endproducts (AGEs) and markers for oxidative stress and inflammation (e.g. 8-OHdG).
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 28851415Yuan Y, Vora N, Sun CL, Li D, Soto-Perez-de-Celis E, Mortimer J, Luu TH, Somlo G, Waisman J, Smith D, Chao J, Katheria V, Synold T, Tran V, Mi S, Levi A, Arsenyan A, Choi J, Zavala L, Yost S, Hurria A. Association of pre-chemotherapy peripheral blood pro-inflammatory and coagulation factors with reduced relative dose intensity in women with breast cancer. Breast Cancer Res. 2017 Aug 29;19(1):101. doi: 10.1186/s13058-017-0895-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arti Hurria, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe longitudinal trajectory of physical functional status and quality of life and determine if the patient assessment measure predicts morbidity in adult breast cancer patients from prior to adjuvant chemotherapy to 6 months after end of treatment. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.